Long-term results of a phase III randomized trial of postoperative radiotherapy with or without carboplatin in patients with high-risk head and neck cancer.

Abstract

BACKGROUND:

The role of postoperative radiotherapy and carboplatin in squamous cell carcinoma of the head and neck (SCCHN) has not been established.

METHODS:

Patients with macroscopically resected stage III/IV SCCHN with high-risk pathologic features (> or =3 lymph nodes, extracapsular extension, perineural or angiolymphatic invasion, or involved margins) were randomized to receive postoperative radiotherapy alone (arm A) or the same radiotherapy plus carboplatin 100 mg/m intravenously once weekly during radiation (arm B). The primary endpoint was 2-year disease-free survival.

RESULTS:

Seventy-six patients were randomized, of whom 72 were eligible and analyzable (36 in each arm). The study was prematurely closed because of slow accrual. With a median follow-up of 5.3 years, the disease-free survival at 2 and 5 years was 71% and 53% in arm B versus 58% (P = .27) and 49% (P = .72) in arm A. The overall survival at 2 and 5 years was 74% and 47% in arm B versus 51% (P = .04) and 41% (P = .61) in arm A. Serious toxicities were infrequent in both arms.

CONCLUSIONS:

We could not demonstrate a benefit with the addition of carboplatin to postoperative radiotherapy, possibly because of insufficient sample size.

• Authors: Athanassios Argiris, Michalis V Karamouzis, Jonas T Johnson, Dwight E Heron, Eugene Myers, David Eibling, Elmer Cano, Susan Urba, Jack Gluckman, Jennifer R Grandis, Yun Wang, Sanjiv S Agarwala
• Journal: The Laryngoscope (Laryngoscope) Vol. 118 Issue 3 Pg. 444-9 (Mar 2008) ISSN: 0023-852X [Print] United States
• PMID: 18091334 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents
• Carboplatin

Topics

• Aged
• Antineoplastic Agents (therapeutic use)
• Carboplatin (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, radiotherapy)
• Combined Modality Therapy
• Female
• Follow-Up Studies
• Head and Neck Neoplasms (drug therapy, radiotherapy)
• Humans
• Male
• Middle Aged
• Postoperative Care
• Risk Factors
• Time Factors